drugset / Trial / NCT00568022

A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

NCT00568022

Phase 1 Completed 9 enrolled R-Pharm
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.

Timeline

Start
2008-02
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixabepilone Small molecule 32 mg/m2 Intravenous
Subject Ixabepilone Small molecule 40 mg/m2 Intravenous
Background Capecitabine Small molecule 1650 mg/m2 Oral
Background Capecitabine Small molecule 2000 mg/m2 Oral

Indications